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Associate Director, Program Management Leader/Clinical Program Management Leader
Johnson & Johnson
Raritan, NJ, United States
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Janssen Research & Development, LLC., a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director, for a combined Program Management Leader (PML)/Clinical Program Management Leader (CPML). This position is part of the Project Management Office (PMO), supporting the Cardiovascular and Metabolism (CVM) business. This position will be based in Raritan, NJ or Spring House, PA and may require up to 10% international and domestic travel.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Research & Development, L.L.C. thrives on a diverse company culture, celebrates the uniqueness of our employees and is committed to inclusion. We are proud to be an equal opportunity employer.
Position Description:
The Associate Director, PML/CPML, in conjunction with the Compound Development Team Leader (CDTL), co-leads the CDT, comprised of global colleagues from Clinical, Regulatory Affairs, Medical Affairs, Commercial, Supply Chain and Safety to support product development, optimization and management needs. Depending on the needs of the product, additional business partners would include: GCDO, Finance, Procurement, Quality, Alliance Management/ Business Development, Legal, Discovery, Product Development & Supply, PD&S, biologics toxicology and clinical pharmacology and GCSO.
PML/CPML is responsible for planning, budgeting, execution, risk management and reporting on program strategy, and coordination of activities across working groups.
The CPML is responsible for supporting the, Clinical Leader (CL) and GCDO as needed for execution of the clinical development programs, post-marketing commitments and responses to Health Authority actions. Primary duties include Strategic Planning; HA Submission Management; Program Information/Communication; Program Timelines, Resource, Risk and Cost Management.
Working in partnership with the CDTL and the CL, the PML/CPML is expected to achieve the following results:
• Guide the CDT/Clinical Team (CT) to meet or exceed goals by providing global cross-functional operational leadership and management in a matrix organization, facilitating issue identification and resolution, problem-solving, risk management, contingency planning and decision-making.
• Manage CDT/CT/PMT information, documentation and team communications to ensure timely and accurate dissemination of the CDT strategy and operational status throughout the Company. Employ the reporting processes and tools established by the PMO and the CVM leadership.
• Lead the planning, execution, control, reporting, and close-out of all compound related work across all functions (e.g. integrated program budget, risk, timeline, resource, and stakeholder management). PML is accountable for alignment between functional groups and CDT strategy such that forecasted benefits are achieved. Ensure program work is conducted in compliance with company processes and polices.
• In co-development programs, manage and align on cross-company activities and objectives and manage Alliance meetings as a member of the Joint Steering/Development Committee (JDC/ JSC)
• Actively manage development programs to ensure that clinical studies are effective executed and delivered on timeline and budget targets.
• Work with the CDTL to rapidly activate the CDT in response to regulatory authority queries or actions. Establish the CDT/CT strategy for the response with concomitant goals and objectives in alignment with the established organizational objectives.
• Contribute to and coordinate compound/clinical team strategy updates over time; provide context and history to new CDT/CT members/ stakeholders.
• Manage the CDT/CT in a manner that fosters and maintains high performance team culture. Utilize team development best practices and facilitate lessons learned to ensure optimal performance.
• At direction of CDTL or CL, chair meetings and represent the CDT/CT at interdepartmental meetings, governance meetings, co-development partnerships, and external meetings such as HA or advisory meetings.
Qualifications
• A minimum of a Bachelor’s degree in life sciences or related field is required.
• A Master’s or Postgraduate degree in life sciences is preferred.
• Professional project management certification (PMP) is desirable.
• A minimum 5 or more years’ pharmaceutical industry experience in Clinical Operations, Clinical Development, Program Management, Early Development or Discovery is required.
• A minimum 3 or more years successful experience managing, or leading global and/or virtual teams is strongly preferred.
• Cardiovascular and Metabolism (CVM) experience is preferred.
• Demonstrated ability to work in a matrix cross-functional team environment, resolve conflict, prioritize projects, and influence teams without formal authority, is required.
• Demonstrated ability to distill complex matters down to their essence and translate into clear communications around actions, decisions and implications is strongly preferred.
• Experience within a matrix organization with record of successful governance body and/or stakeholder management is strongly preferred.
• Budgeting experience is Preferred.
• Important skill set: strong team collaborator is required.
This position will be based in Raritan, NJ or Spring House, PA and may require up to 10% international and domestic travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.